Dr. Weeks’ Comment: These studies are damning for those who endorse omega 3 fish oil. We endorse the healthy version of omega 6 oil – the SEED oils which are not process in a way to make them rancid and oxidized. Stop the fish oil. It interferes with healthy oil metabolism.

Randomized Controlled Trial

JAMA   2020 Dec 8;324(22):2268-2280.

 doi: 10.1001/jama.2020.22258.

Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial

Stephen J Nicholls ¹, et al  DOI: 10.1001/jama.2020.22258

Abstract

Importance: It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.

Objective: To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.

Design, setting, and participants: A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.

Interventions: Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins.

Main outcomes and measures: The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

Results: When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).

Conclusions and relevance: Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant differencein a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.

AND

Fish Oil Fears: Study Finds Prescription-Strength Fish Oil Could Cause Some Harm

By John ShumwayFebruary 10, 2021 

PITTSBURGH (KDKA) – Fish Oil and its Omega-3 Fatty Acids are so popular as a supplement it accounts for about $2 billion in sales globally each year.

But, a new study in the Journal of the American Medical Association could send shockwaves through fish oil believers.

Dr. Steven Nissen a cardiologist from the Cleveland Clinic says the study used prescription-strength fish oil in 600 locations in 20 countries to determine its benefit in reducing heart issues.

“This is a drug that is like the fish oil people buy over the counter, but much, much more effective,” Dr. Nissen explained. “It has a higher amount of what we call omega-three fatty acids.”

And the result?

“There was absolutely no reduction in cardiovascular events using this very active fish oil,” he said.

This result comes just a year after another study showed positive impacts of fish oil but Dr. Nissen says that study was flawed by using a placebo that was actually harmful.

“The earlier drug that was favorable and is being widely marketed got approved by the FDA, but we think it’s a mistake,” he said.

Dr. Nissen is emphatic about that because this new study used harmless corn oil as the placebo.

“In patients treated with the fish oil product, there was a 69% higher risk of atrial fibrillation,”Dr. Nissen said. “So that actually some harms associated with taking the fish oil, and that we think is also an important finding.”

Knowing people believe in the benefits in cognitive health, weight loss, better eyesight, and the list goes on but Dr. Nissen says the study results are crucial.

“It’s also important for the public,” he said. “Because people believe that fish oil is beneficial.”

The potential for harm he says is something people need to understand.

“It’s really kind of a wake-up call,” he explained. “When you see a study like this where the most potent prescription-grade fish oil didn’t have any favorable effects. It certainly doesn’t suggest that over the counter fish oil is something that shouldn’t be widely consumed.”

But when asked if people should dump their fish oil supply Dr. Nissen says it’s important to understand that the participants in the study received prescription-strength fish oil many times stronger than what anyone can purchase over the counter.

Also, if fish oil is a regular part of your day a sudden stop could cause issues so you should talk to your doctor and decide your level of risk vs. benefit.